Pregart clinical trial situation in Uganda

The recruitment of trial participants on the Ugandan arm of the Pregart study kicked off on the 28th of September 2021 and it has been running to-date for approximately 17 weeks.

So far, the team has managed to enroll about 40 participants, of these, 3 have delivered, and all mothers and babies are faring well.

An unfortunate encumbrance in picking up recruitment numbers occurred mostly from the current global Covid-19 pandemic and the related setbacks. Solutions to mitigate this situation have been put in place for a hopefully better outcome. Aside from these overt challenges, the trial thus far is progressing steadily with a hope that it shall pick up to enable the team meet project’s end goals.


Update on Pregart clinical trial participant recruitment as of 13th October 2021

The Ugandan team started participant recruitment on 21st September 2021, with a total of 8 participants recruited to date. Prior to recruitment we had retraining of the Trial site staff on the Protocol, data collection tools and SOPs, to enable smooth understanding and running of participant recruitment.

Retraining of on PREGART Protocol, SOPs and Data collection tools at MildMay Hospital

 

 

Screening and Consenting
Participant being reviewed by the clinician
Lab personnel prepping to take off sample from a trial participant and sample that was taken off


Hawassa University Pregart clinical trial project PhD candidates presented their thesis concept note

One of the Pregart clinical trial project deliverable is clinical trial capacity building in Africa.  Accordingly, one of the project consortium institutions, Karolinska Institute (KI) in Sweden will enroll 4 PhD and 2 -Post doc students from Hawassa University and Makerere University. Two of the PhD candidates from Hawassa university; Mr. Siraj Hussein from department of Medical Laboratory Science and Dr. Abel Gedefaw from School of Medicine presented their thesis concept note to their advisors on September 21/2021 at Hawassa University project office. Professor Eleni Aklilu from KI and Professor Eyasu Mekonnen from Addis Ababa University attended the presentation onsite at the office while Professor Stefano Vella from KI attended online using zoom. The PhD candidate’s registration process at KI will be completed in the coming two months.

One of the PhD candidates (Mr. Siraj Hussien) presenting his thesis concept note. Professor Eleni Aklilu and Professor Eyasu Mekonnen attending the presentation at Hawassa University Pregart project office

 

Professor Stefano Vella from KI attending the PhD candidate thesis concept note

Hawassa University President welcome Pregart clinical trial investigators

Hawassa University president, Dr. Ayano Beraso, warmly welcome Pregart clinical trial investigators on September 20/2021 at the president office. The visiting investigators, Professor Eleni Aklilu from Karolinska institute and Professor Eyasu Mekonnen from Addis Ababa university, has briefed the president on the trial implementation status progress and the recent activity plan. The President reassured to the team that he will continue following up of the project implementation in order to achieve the project deliverables.

Pregart clinical trial investigators with Hawassa University president during visit at the president office.

 

Professor Eleni with Dr. Ayano ( President) during president visit at his office.

 

Hawassa University President welcome Pregart investigators at President office.

Pregart project investigators conducted trial hospital site visit

Professor Eleni Aklilu from Karolinska institute, Professor Eyasu Mekonnen from Addis Ababa university with Hawassa University trial lead team members, conducted site visit to one of the trial site hospitals, Hawassa University Comprehensive Specialized hospital on September 20/2021. The investigators evaluated the quality of data collection, GCP compliant status during trial implementation and provide positive feedback to the team for future strengthening of the trial.

Professor Eleni and Professor Eyasu evaluating participant folder during Hawassa University comprehensive Specialized hospital site visit
Hawassa University comprehensive Specialized hospital trial site staffs briefing on the implementation process to the visiting investigators at the trial site office.

Pregart clinical trial Ethiopia trial lead team conducted project implementation status review meeting

A two-day review meeting, September 21-22/2021, was conducted on the Ethiopia Pregart clinical trial implementation status at the University project office.  Most of the Ethiopia trial lead team (Dr. Birkneh Tilahin, Professor Eleni Aklilu, Professor Eyasu Mekoknnen , Dr. Abel Gedefaw , Dr. Dejene Hailu , Mr Siraj , Sintayehu Hailu , Negede Yohannes , Biruk kebede and others ) attended the meeting.  The trial current implementation status, challenges and anticipated risks presented for discussion by three presentations. After in depth discussions, the trial lead team decided to initiate the trial recruitment in all the trial sites, fasten the recruitment process in the already initiated trial sites, finalize the PhD candidate’s thesis concept note, request protocol amendment to respective ethical and regulatory institutions to avoid protocol related bottlenecks of participant recruitment.

Trial lead team project implementation status review workshop meeting at the project office

 

Ethiopia Pregart project trial lead team review meeting workshop at project office

 

Trial lead team review meeting workshop at Hawassa University project office

Pregart clinical trial project in Ethiopia has started participant recruitment in the third trial site

After the long impact of Covid-19 pandemic to the clinical trial implementation timeline, the Hawassa University trial lead team conducted site initiation visit from September 1-5/ 2021 and started participant recruitment per protocol at the third trial site in Bahirdar Felegehiwot Comprehensive Specialized hospital.

Site initiation meeting with the site research staffs at Bahirdar Felegehiwot Comprehensive Specialized hospital.

 

Research staffs training at Bahirdar Felegehiwot Comprehensive Specialized hospital during site initiation

 

The first recruited participant sample analysis at Bahirdar Felegehiwot Comprehensive Specialized hospital

Pregart clinical trial project in Ethiopia has started participant recruitment in the second trial site

After the long impact of Covid-19 pandemic to the clinical trial implementation timeline, the Hawassa University trial lead team conducted site initiation visit from August 26-30/ 2021 and started participant recruitment per protocol at the second trial site in Gondor Comprehensive Specialized hospital.

Site initiation meeting with the site research staffs at Gondor Comprehensive Specialized hospital

Patient recruitment begins in Ethiopia after pandemic-related difficulties

The Covid-19 pandemic caused significant delays in starting the patient recruitment phase in both Ethiopia and Uganda. Finally, after intense work, patient recruitment finally began at Hawassa University Hospital on May 25, 2021. Recruitment work will now continue in the remaining hospitals in both Ethiopia and Uganda. Here are some pictures of the recruitment phase in Ethiopia.

 

Participants with the study site team. (Picture taken with participant consent)

 

Participant signing consent

 

Study clinician collecting data from participant (picture taken with participant consent)

PREGART Clinical Trial Database Development Training for Project Staff Using REDCap Software - Shasmene, Ethiopia, April 26-29, 2021

A training course was held in Shasmene, Ethiopia, from the 26 to the 29 of April 2011 aimed to capacitate the research team and project staff on application of REDCap software on PREGART projects data entry and reporting so that the program will generate a high quality data for the project.

Main contents covered in the training were: Introduction to data, data quality, data quality dimensions; Introduction to REDCap software (Definitions, Important terminologies relevant to REDCap, REDCap features); Getting started with REDCap software; Creating New eCRF; Access & editing eCRF; Exporting data from REDCap to other Software.

Practical Session included: entering a fictitious data into the REDCap database; Identify limitations and errors in the CRFs created in the REDCap software; Identify data type as per the CRF; Save Data; Export Data variables; Edit and Save data dictionary (codebook).

Six project staff participated in the training: two trial site supervisors (one male and one female); two research team members; one clinical laboratory assistant; one project manager.

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